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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K203449
Device Name F&P Visairo NIV Mask Range
Applicant
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place, East Tamaki
Auckland,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place, East Tamaki
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/23/2020
Decision Date 04/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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